Description
Maribavir is used to treat cytomegalovirus (CMV) infection and disease in patients who have received a transplant, and have been treated with other medicines (eg, ganciclovir, valganciclovir, cidofovir, foscarnet) that did not work well.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of maribavir in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of maribavir in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Colchicine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Apalutamide
- Bedaquiline
- Benzhydrocodone
- Budesonide
- Carbamazepine
- Codeine
- Dabigatran Etexilate
- Dihydrocodeine
- Dihydroergotamine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Ensartinib
- Enzalutamide
- Fentanyl
- Fosphenytoin
- Ganciclovir
- Haloperidol
- Hydrocodone
- Lefamulin
- Lumacaftor
- Mavorixafor
- Meperidine
- Methadone
- Mitotane
- Morphine
- Morphine Sulfate Liposome
- Oxycodone
- Paclitaxel
- Paclitaxel Protein-Bound
- Phenobarbital
- Phenytoin
- Posaconazole
- Relugolix
- Repotrectinib
- Rifabutin
- Rifampin
- Roflumilast
- St John's Wort
- Sufentanil
- Tenofovir Alafenamide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information insert and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
If you are unable to swallow the tablet whole:
- You may break apart or crush the tablets and mix with drinking water. Do not use any other liquid.
- Ask your doctor how much water you will need for your dose.
- Gently swirl the container and swallow the mixture right away.
- Rinse the container with 15 mL of drinking water and swallow the mixture. Repeat this step until no pieces of tablet are left in the container.
You may also give the medicine through a nasogastric tube or orogastric tube:
- Place 2 tablets into the syringe and add 30 mL of drinking water.
- Shake the syringe well for about 30 to 45 seconds or until the tablets are completely dispersed.
- Give the mixture right away into the feeding tube.
- Add 15 mL of drinking water into the same syringe and flush through the tube. Repeat this step until no pieces of tablet are left in the syringe.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For the treatment cytomegalovirus (CMV) infection or disease:
- Adults and children 12 years of age and older weighing 35 kilograms (kg) or more—400 milligrams (mg) (2 tablets) 2 times a day.
- Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
- For the treatment cytomegalovirus (CMV) infection or disease:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
You may store the mixture for up to 8 hours.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with ganciclovir (Cytocvene®) or valganciclovir (Valcyte®).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Change of taste
- diarrhea
- loss of taste
- nausea
- unusual tiredness or weakness
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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